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Efficacy and Safety of Pazopanib Monotherapy After First-line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Asian Women

12 de febrero de 2015 actualizado por: GlaxoSmithKline

A Study to Evaluate Efficacy and Safety of Pazopanib Monotherapy in Asian Women Who Have Not Progressed After First-line Chemotherapy for Advanced Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma - An Extension Study to VEG110655

This is a study to determine whether therapy with pazopanib is effective and safe in Asian women with epithelial ovarian, fallopian tube or primary peritoneal cancer whose cancer has not progressed on first-line chemotherapy.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This study is an extension study to the VEG110655 study. The parent study, VEG110655, was designed to evaluate whether pazopanib 800 mg daily for 52 weeks will prolong progression free survival (PFS) in women diagnosed with ovarian, fallopian tube or primary peritoneal cancer. These women will have obtained stable disease, a complete remission, or a partial remission after debulking surgery and at least five cycles of chemotherapy (taxane/platinum). This extension study will evaluate safety and efficacy outcomes of pazopanib monotherapy and placebo in an Asian population with the same indication as the parent study.

Tipo de estudio

Intervencionista

Inscripción (Actual)

145

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Corea, república de
      • Seoul, Corea, república de, 135-710
        • GSK Investigational Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • GSK Investigational Site
  • Porcelana
      • Beijing, Porcelana, 100044
        • GSK Investigational Site
      • Beijing, Porcelana, 100021
        • GSK Investigational Site
      • Beijing, Porcelana, 100853
        • GSK Investigational Site
      • Shanghai, Porcelana, 200032
        • GSK Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, Porcelana
        • GSK Investigational Site
    • Jiangsu
      • Nanjing, Jiangsu, Porcelana, 210009
        • GSK Investigational Site
    • Liaoning
      • Shenyang, Liaoning, Porcelana, 110022
        • GSK Investigational Site
    • Shandong
      • Jinan, Shandong, Porcelana, 250012
        • GSK Investigational Site
    • Sichuan
      • Chengdu, Sichuan, Porcelana, 610041
        • GSK Investigational Site
    • Zhejiang
      • Hangzhou, Zhejiang, Porcelana, 310006
        • GSK Investigational Site
      • Hangzhou, Zhejiang, Porcelana, 310022
        • GSK Investigational Site
  • Taiwán
      • Taipei, Taiwán, 104
        • GSK Investigational Site
      • Taipei, Taiwán, 112
        • GSK Investigational Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • written informed consent
  • At least 18 years old.
  • Histologically confirmed, International Federation of Gynecology and Obstetrics (FIGO) stage II-IV epithelial ovarian, fallopian tube or primary peritoneal carcinoma that was treated with surgical debulking and at least five cycles of platinum-taxane doublet chemotherapy.
  • Study randomization at least 3 weeks and not more than 12 weeks from the date of the last chemotherapy dose, and all major toxicities from the previous chemotherapy must have resolved.
  • No evidence of disease progression
  • Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
  • Able to swallow and retain oral medication.
  • Adequate hematologic, hepatic, and renal system function as follows:

Hematologic

  • Absolute neutrophil count (ANC) at least 1.5 X 10^9/L
  • Hemoglobin at least 9 g/dL (or 5.59 mmol/L)
  • Platelets at least 100 X 10^9/L
  • Prothrombin time (PT) or international normalized ratio (INR) up to 1.2 X ULN
  • Activated partial thromboplastin time (aPTT) up to 1.2 X ULN Hepatic
  • Total bilirubin up to 1.5 X ULN
  • AST and ALT up to 2.5 X ULN Renal
  • Serum creatinine up to 1.5 mg/dL

Or, if greater than 1.5 mg/dL:

Calculated creatinine clearance at least 50 mL/min Urine Protein

  • Urine protein is 0, trace, or +1 determined by dipstick urinalysis, or < 1.0 gram determined by 24-hour urine protein analysis.
  • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) OR childbearing potential, and agrees to use adequate contraception.

Exclusion Criteria:

  • Either (a) bulky disease, or (b) any residual disease which in the opinion of the investigator will need imminent second-line therapy
  • Synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless certain conditions are met.
  • Clinically significant gastrointestinal abnormalities
  • Prolongation of corrected QT interval (QTc) > 480 msecs
  • History of any one or more cardiovascular conditions within the past 6 months prior to randomization
  • Poorly controlled hypertension
  • History of cerebrovascular accident (including transient ischemic attacks), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months prior to randomization
  • Major surgery (including interval debulking) or trauma within 28 days, or minor surgical procedures within 7 days, prior to randomization, or has any non-healing wound, fracture, or ulcer.
  • Evidence of active bleeding or bleeding diathesis.
  • Hemoptysis within 6 weeks prior to randomization.
  • Endobronchial metastases.
  • Serious and/or unstable pre-existing medical (e.g., uncontrolled infection), psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
  • Investigational or anti-VEGF anticancer therapy prior to study randomization.
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib.
  • Prior or concurrent invasive malignancies that currently or within the last 5 years show/ed activity of disease (except ovarian, fallopian tube, or peritoneal cancer, or concurrent endometrial cancer FIGO stages IA/B)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: placebo
comparador de placebo
Droga: Placebo comparator
Placebo 800 mg daily for 24 months
Experimental: pazopanib
experimental medication
Droga: Pazopanib
Pazopanib 800 mg daily for 24 months

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression-free Survival (PFS)
Periodo de tiempo: From randomization until evidence of progressive disease or death, whichever occurred first (average of 15.2 months)
PFS is defined as the time interval between randomization and evidence of progressive disease (PD), as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, or death, whichever occurred first. A visit-based analysis approach to determine participants' dates of progression was applied in the analysis method. PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants who were alive and had not progressed at the time of analysis were censored at the date associated with the last visit with adequate assessment.
From randomization until evidence of progressive disease or death, whichever occurred first (average of 15.2 months)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival
Periodo de tiempo: From randomization until death due to any cause (average of 29.4 months)
Overall survival is defined as the time interval from the date of randomization to the date of death due to any cause.
From randomization until death due to any cause (average of 29.4 months)
PFS by Gynaecologic Cancer Intergroup (GCIG) Criteria
Periodo de tiempo: From randomization to the earliest date of disease progression per GCIG criteria or death due to any cause (average of 15.2 months)
PFS by GCIG criteria is defined as the time from the randomization date to the earliest date of disease progression (PD) per GCIG criteria or death due to any cause. Per GCIG criteria, an objective progression is defined as the earliest event of either tumor progression based on RECIST v1.0 or confirmed CA-125 progression. A participant is counted as "Progressed per RECIST" if the radiological PD per RECIST occurred prior to or on the same day as CA-125 progression. A participant is counted as "Progressed per CA-125" if the radiological PD occurred after CA-125 progression. Per RECIST, PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants who were alive and had not progressed at the time of analysis were censored at the date associated with the last visit with adequate assessment.
From randomization to the earliest date of disease progression per GCIG criteria or death due to any cause (average of 15.2 months)
Number of Participants With Any Dose Reduction or Any Dose Interruption
Periodo de tiempo: From Week 1 until the end of the treatment period (up to Study Week 108)
Dose interruptions or reductions may have been required following potential drug-related toxicities. As a general rule, if dose reduction of investigational product (IP) was necessary, the dose should have been reduced stepwise by 200 mg at each step, and the participant should have been monitored for 10 to 14 days. If toxicity recurred or worsened during this monitoring time, the IP could have been interrupted and/or the dose of IP further decreased, with continued monitoring for an additional 10 to 14 days, and so on. The cut off for these data was October 12, 2012.
From Week 1 until the end of the treatment period (up to Study Week 108)
Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)
Periodo de tiempo: From Week 1 until the end of the treatment period (up to Study Week 108)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalizaton or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. See the non-serious AE/SAE module for a list of specific events.
From Week 1 until the end of the treatment period (up to Study Week 108)
Number of Participants With Any On-therapy AE and Any AE Related to Study Treatment
Periodo de tiempo: From Week 1 until the end of the treatment period (up to Study Week 108)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. On-therapy AEs were those reported from the first day that randomized study drug was received to 28 days after the last dose of randomized study drug, and within 28 days of dose interruption. Relatedness was assessed by the Investigator.
From Week 1 until the end of the treatment period (up to Study Week 108)
Number of Participants With Any Grade 3 or 4 AE
Periodo de tiempo: From Week 1 until the end of the treatment period (up to Study Week 108)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. The NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0 was used to grade AEs per the following scale to assess severity: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling AE; Grade 5, death related to AE.
From Week 1 until the end of the treatment period (up to Study Week 108)
Number of Participants With the Indicated On-therapy Grade 3-5 AEs
Periodo de tiempo: From Week 1 until the end of the treatment period (up to Study Week 108)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. On-therapy AEs were those reported from the first day that randomized study drug was received to 28 days after the last dose of randomized study drug, and within 28 days of dose interruption. The NCI-CTCAE Version 3.0 was used to grade AEs per the following scale to assess severity: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling AE; Grade 5, death related to AE. ALT=alanine aminotransferase; AST=aspartate aminotransferase.
From Week 1 until the end of the treatment period (up to Study Week 108)
Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment, Dose Interruption, and Dose Reduction
Periodo de tiempo: From Week 1 until the end of the treatment period (up to Study Week 108)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Dose interruptions or reductions may have been required following potential drug-related toxicities. As a general rule, if dose reduction of investigational product (IP) was necessary, the dose should have been reduced stepwise by 200 mg at each step, and the participant should have been monitored for 10 to 14 days. If toxicity recurred or worsened during this monitoring time, the IP could have been interrupted and/or the dose of IP further decreased, with continued monitoring for an additional 10 to 14 days, and so on.
From Week 1 until the end of the treatment period (up to Study Week 108)
Number of Participants With Any SAE, Any SAE Related to Study Treatment, and Any Fatal SAE
Periodo de tiempo: From Week 1 until the end of the treatment period (up to Study Week 108)
An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalizaton or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. See the non-serious AE/SAE module for a list of specific events. Relatedness was assessed by the Investigator.
From Week 1 until the end of the treatment period (up to Study Week 108)
Number of Participants With the Indicated Worst-case On-therapy Blood Pressure Shifts From Baseline
Periodo de tiempo: From Week 1 until the end of the treatment period (up to Study Week 108)
Systolic blood pressure (SBP) and Diatolic blood pressure (DBP) are measured in millimeters of mercury (mmHg). A participant could have been counted in more than one shift category. Participants who experienced shifts in both SBP and DBP are represented under each individual parameter. A worst-case on-therapy shift is defined as the worst shift that occurred at any time during the treatment period.
From Week 1 until the end of the treatment period (up to Study Week 108)
Number of Participants With the Indicated Worst-case On-therapy Shift From Baseline in Bazett's Corrected QT Interval (QTc)
Periodo de tiempo: From Week 1 until the end of the treatment period (up to Study Week 108)
12-lead ECGs were obtained at the scheduled visits. A worst-case on-therapy shift is defined as the worst shift that occurred at any time during the treatment period. The QTc is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. In general, the faster the heart rate the shorter the QTc. If a QTc >=500 milliseconds (msec) was noted on a scheduled or unscheduled electrocardiogram (ECG), then two additional ECGs should have been obtained within 5 minutes to confirm the abnormality. The average QTc was determined from the three ECG tracings by manual evaluation and was used to determine continued eligibility.
From Week 1 until the end of the treatment period (up to Study Week 108)
Number of Participants With the Indicated Worst-case On-therapy Hematology Parameter Grade Shifts From Baseline Grade
Periodo de tiempo: From Week 1 until the end of the treatment period (up to Study Week 108)
Grade shifts from Baseline were assessed as any grade increase (AGI), increase to Grade (G) 3 (ITG3), and increase to Grade 4 (ITG4). Toxicities were graded according to the National Cancer Institute common toxicity criteria (NCI-Common Toxicity Criteria for Adverse Events), version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades (G) 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: G1, mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; G2, moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); G3, severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; G4, Life-threatening consequences; urgent intervention indicated.; G5, death related to AE.
From Week 1 until the end of the treatment period (up to Study Week 108)
Number of Participants With the Indicated Worst-case On-therapy Chemistry Parameter Grade Shifts From Baseline Grade
Periodo de tiempo: From Week 1 until the end of the treatment period (up to Study Week 108)
Grade shifts from Baseline were assessed as any grade increase (AGI), increase to Grade (G) 3 (ITG3), and increase to Grade 4 (ITG4). Toxicities were graded according to the National Cancer Institute common toxicity criteria (NCI-Common Toxicity Criteria for Adverse Events), version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades (G) 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: G1, mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; G2, moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); G3, severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; G4, Life-threatening consequences; urgent intervention indicated.; G5, death related to AE.
From Week 1 until the end of the treatment period (up to Study Week 108)
Number of Participants With the Indicated Worst-case Eastern Cooperative Oncology Group (ECOG) Performance Status Shifts From Baseline Grades of 0, 1, and 2
Periodo de tiempo: From Week 1 until the end of the treatment period (up to Study Week 108)
The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead.
From Week 1 until the end of the treatment period (up to Study Week 108)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

GlaxoSmithKline

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de septiembre de 2010

Finalización primaria (Actual)

1 de octubre de 2012

Finalización del estudio (Actual)

1 de enero de 2014

Fechas de registro del estudio

Enviado por primera vez

21 de octubre de 2010

Primero enviado que cumplió con los criterios de control de calidad

21 de octubre de 2010

Publicado por primera vez (Estimar)

25 de octubre de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

3 de marzo de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

12 de febrero de 2015

Última verificación

1 de febrero de 2015

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 114012

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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